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The study will consist of two parts: a dose-escalation part (Part 1) and a dose expansion part (Part 2). In both study parts, SSGJ-705 will be administered,the administration duration may be adjusted based on outcomes of previous patients if necessary) followed by safety, PK, PD, potential anti tumor effects and immunogenicity evaluation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HER2-expressing Solid Tumors | Experimental | SSGJ-705 Administered via intravenous (IV) infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SSGJ-705 | Drug | 0.1, 1, 3, 6, 10, 15 or 20mg/kg, IV, Day 1, 8, 15 of each treatment cycle, up to disease progression or intolerable toxicity, death, early withdrawal from the study or loss to follow-up, withdrawal of consent, or the end of the treatment period, whichever occurs first. Every 4 weeks a treatment cycle. |
| Measure | Description | Time Frame |
|---|---|---|
| DLT | Dose-limiting toxicity(part 1) | At the end of Cycle 1 (each cycle is 28 days) |
| MTD | maximum tolerated dose(part 1) | up to 1 years |
| RP2D | Objective response rate (ORR) per RECIST 1.1 criteria according to investigators recommended Phase II dose(part 1) | up to 1 years |
| ORR | Objective response rate (ORR) per RECIST 1.1 criteria according to investigators assessment(part 2) | up to 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | the safety of SSGJ-705 in patients with advanced or metastatic HER2-expressing solid tumors who have failed standard treatment | up to 1 years |
| Maximum Plasma Concentration (Cmax) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Lili Zheng, PMD | Contact | 18511272561 | zhenglili@3sbio.com |
| Name | Affiliation | Role |
|---|---|---|
| Zefei Jiang, PhD | The Fifth Medical Center of the People's Liberation Army | Principal Investigator |
| Ying Cheng, PhD | Jilin Provincial Cancer Hospital | Principal Investigator |
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To evaluate the Cmax of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments
| up to 1 years |
| Area Under the Curve (AUC) | To evaluate the AUC of single and multiple doses of SSGJ-705 in patients with advanced or metastatic HER2 expressing solid tumors who have failed standard treatments | up to 1 years |
| incidence of anti-609A antibodies | incidence of anti-609A antibodies | up to 1 years |
| Median Progression-free Survival (PFS) | The Kaplan-Meier method will be used to estimate median PFS. | up to 1 years |
| Overall Survival (OS) | The Kaplan-Meier method will be used to estimate median OS. | up to 1 years |